(29 days)
Cell cultures to be used as hosts for the isolation and identification of specific viruses. The subject of this 510(k) Notification, the cell lines HEL, HFF, LLC-MK2, MvlLu, NCI H292, Vero and WI-38 are susceptible to and can be used in the isolation and confirmation of the following viruses from clinical samples:
| CELL LINE/ORIGIN | SPECIFIC VIRUSES |
|---|---|
| HEL/Human Embryonic Lung | Adenovirus, CMV, Echovirus, HSV, |
| Poliovirus, Rhinovirus, Vesicular stomatitis | |
| (Indiana Strain) virus and VZV. | |
| HFF/Human Foreskin Fibroblasts | Adenovirus, CMV, Echovirus, HSV, Mumps, |
| Poliovirus, Rhinovirus, VZV. | |
| LLC-MK2, Original/Rhesus Monkey Kidney | Poliovirus type 1, Enterovirus, Rhinovirus, |
| Myxovirus and Poxvirus groups. | |
| MvlLu/Mink Lung | HSV, CMV. |
| NCI-H292/Human, Pulmonary muco- | |
| epidermoid carcinoma. | Vaccinia virus, HSV, Adenovirus, BK |
| polyomavirus, Reoviruses, Measles virus, | |
| RSV, some strains of Influenza type A, most | |
| Enteroviruses and Rhinoviruses, Parainfluenza | |
| and Mumps. | |
| Vero/African Green Monkey | Adenovirus, Coxsackie B, HSV, Measles, |
| Mumps, Poliovirus type 3, Rotavirus, Rubella | |
| WI-38/Human Lung | Adenovirus, CMV, Echovirus, HSV, |
| Influenza, Mumps, Poliovirus, Rhinovirus, | |
| RSV, VZV. |
FreshCells™ are indicated for use in the isolation of various viruses and Chlamydia from clinical specimens. Viruses and Chlamydia are intracellular parasites which can be cultured or grown only in specific cellular hosts. They cause a variety of diseases in man with some virus infections being lethal, particularly if the individual is immunocompromised. With the introduction of several new and specific antiviral drugs over the last several years, the need to determine the identity of the viral agent has become even more important. Culture of viruses in specific cell lines has become the standard for the identification of these viruses.
The subject device provides HEL, HFF, LLC-MK2, MVILu, NCI H292, Vero and WI-38 cells (in addition to MRC-5, McCOY, BGMK, and CV-1, under 510 (k) K936271 and A549 and HEp-2, under 510(k) K962306 which have previously been cleared for marketing under the same name, Fresh Cella™) as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period.
The provided text describes the 510(k) submission for "FreshCells™" cell cultures, intended for the isolation and identification of specific viruses. This submission is for a biological product (cell cultures used in diagnostic tests), not an AI/ML powered device. As such, the requested information regarding acceptance criteria for an AI device, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment is not applicable to this document.
The document primarily focuses on demonstrating substantial equivalence to a predicate device based on:
- Technological Characteristics Comparison: Showing that the source of the cell line, the format (nearly confluent monolayers), and the intended use are the same as the predicate device.
- Non-Clinical Tests: Characterizing the product based on appearance, growth characteristics, sterility, isoenzyme analysis, and virus susceptibility.
Essentially, the "device" here is a biological reagent (cell cultures), and the evaluation is about its quality and suitability for its intended biological diagnostic purpose, not about the performance of an algorithm.
§ 864.2280 Cultured animal and human cells.
(a)
Identification. Cultured animal and human cells are in vitro cultivated cell lines from the tissue of humans or other animals which are used in various diagnostic procedures, particularly diagnostic virology and cytogenetic studies.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.